ArthritisBIOPSYNNCT03417167
Indications and Interest of US-guided Synovial Biopsies Performed in Clinical Practice
An observational study of Arthritis, run by Nantes University Hospital at 17 sites in France.
Trial summary
Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- US-guided synovial biopsy
- How many people
- 201 participants
- Where
- 17 sitesFrance
- Study dates
- 14 Feb 2018to 11 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age under 18 year old, pregnancy, breastfeeding
Who may be able to join
- All patients undergoing an US-guided synovial biopsy in clinical practice in the context of an arthritis of unknown origin
Who cannot join
None listed.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Chu d'Angers
Angers, 49000
CHU de Bordeaux
Bordeaux, 33000
Chu Brest
Brest, 29000
CHU CAEN
Caen, 14000
Chu de Dijon
Dijon, 21000
CHD La Roche-sur-Yon
La Roche-sur-Yon, 85000
AP-HM
Marseille, 13000
Chu de Montpellier
Montpellier, 34000
CHU de Nancy
Nancy, 54000
CHU de Nice
Nice, 06000
AP-HP
Paris, Lariboisière, 75475
AP-HP
Paris, Saint-Antoine, 75012
AP-HP
Paris, Salpétrière, 75013
CHU de Poitiers
Poitiers, 86000
Chu de Rennes
Rennes, 35000
Chu de Strasbourg
Strasbourg, 67000
Chu de Toulouse
Toulouse, 31000
About this study
Official title: "Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"
Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.
Read the detailed description
In this study, the investigators will collect all the synovial biopsies performed in clinical practice in 18 Rheumatology Unit throughout France. All the participants received a standardized training on US-guided synovial biopsies. For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form. The investigator will determine the number of cases where the synovial biopsy allows drawing a definite diagnosis.
- Conditions
- Arthritis
- Being tested
- US-guided synovial biopsy
- Keywords
- synovial biopsy, US guided synovial biopsy
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided synovial biopsyOther
Needle Synovial biopsy performed using a Tru-cut® device.
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cases where the synovial biopsy allows drawing a definite diagnosis
Final diagnosis will be classified in 5 groups: infectious, crystal induced arthritis, tumoral, inflammatory rheumatisms, others (amyloidosis etc …)
Measured: 10 days
Secondary outcomes (1)
Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology
For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start14 Feb 2018
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Le Goff, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417167
- Sponsor's protocol ID
- RC17_0440
- Acronym
- BIOPSYN
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"
- ClinicalTrials.gov ID
- NCT03417167
- Acronym / sponsor ID
- BIOPSYN / RC17_0440
- Conditions
- Arthritis
- Keywords
- synovial biopsy, US guided synovial biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.
Detailed description
In this study, the investigators will collect all the synovial biopsies performed in clinical practice in 18 Rheumatology Unit throughout France. All the participants received a standardized training on US-guided synovial biopsies. For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form. The investigator will determine the number of cases where the synovial biopsy allows drawing a definite diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age under 18 year old, pregnancy, breastfeeding
Key inclusion criteria (1 listed)
- All patients undergoing an US-guided synovial biopsy in clinical practice in the context of an arthritis of unknown origin
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US-guided synovial biopsyNeedle Synovial biopsy performed using a Tru-cut® device. | Other | – |
Primary outcome
number of cases where the synovial biopsy allows drawing a definite diagnosis
Time frame: 10 days
Final diagnosis will be classified in 5 groups: infectious, crystal induced arthritis, tumoral, inflammatory rheumatisms, others (amyloidosis etc …)
1 secondary outcome
Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Le Goff principal investigator
Nantes University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Nantes University Hospital at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of cases where the synovial biopsy allows drawing a definite diagnosis (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.